The India Pharmaceutical Inc. is on a growth highway. PriceWaterhouseCoopers (PWC) in its publication 'Pharma 2020: The Vision' centering on demographic, epidemiological and economic factors has prophesied about significant growth in the industry in the coming years. Another assessment by McKinsey through its 'Indian Pharma 2015' predicts that the Indian pharma market will move into the world's top 10 pharma markets. The assessment is based on six trends that will influence the growth of the market-doubling of disposable incomes and the number of middle-class households, expansion of medical infrastructure, greater penetration of health insurance, rising prevalence of chronic diseases, adoption of product patents and aggressive market penetration driven by relatively smaller companies.

Product patent, an outcome of the third amendment to the Patent Act, 1970 aimed at conforming India's patent law to the requirements set forth by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has become significant in changing the businesses of the indigenous generic pharmaceutical industry. On one hand it is being instrumental in raising the Research and Developmental activity in the area of new drug development whereas on the other hand it has propelled the industry towards acquiring innovative strategies to conduct business.

One strategy in place is opposing patents on grounds of invalidity amongst others. The Post-Grant Opposition procedure, new to the Indian patent law, begins with the filing of a notice of opposition within one year of the patent grant. A patent application can also be opposed before the grant of a patent through Pre-Grant Opposition procedure. The grounds for post-grant opposition are identical to those for pre-grant opposition, and allow another pre-litigation mechanism for patent invalidation.

The country's first product patent, granted in the amended patent regime to Swiss pharmaceutical company Roche on its Hepatitis C drug Pegasys being opposed by Mumbai-based drug maker Wockhardt may be the country's first post-grant opposition. Recently Mumbai-based Sun Pharmaceuticals Ltd. has filed a post-grant opposition in respect to a patent relates to sustained-release microparticle of risperidone issued to Janssen Pharmaceutica N.V.

Indian pharmaceutical firms, which make most of their revenues and profits from the manufacture of generic, drugs, are set to play a larger role with the provision of post-grant opposition, generics companies will get a new opportunity to argue against the unsubstantiated claims made by the patent holder without going to court of law or infringing the patent, both of which are expensive options. Another facet is that quality of patents would be enhanced through this meaningful approach.

The growth of knowledge economy has led to a surge in patenting resulting in patent office backlogs hence raising concerns, in some cases, of granting of patents with insufficient quality or with inadequate search of prior art. A post grant opposition has the potential to improve patent quality, reveal overlooked prior art, and reduce subsequent litigation.